Under the German Narcotic Drugs Act (BtMG), the Federal Ministry of Health is authorized to include substances or preparations, which are not medicines in Annexes I to III, in urgent cases, required as a result of the extent of abuse and the direct or indirect risks to health, to ensure safety or monitoring of the trafficking in narcotics, by ordinance without prior consent of the Federal Council (Bundesrat). A measure adopted on the basis of that provision shall cease to be effective after one year (see § 1 paragraph 3 BtMG). However, owing to the often inadequate data on mode of action, hazard to human health, addictive potential and spread, the stringent requirements "extent of abuse" and "direct/indirect health risk" are often hard to fulfil. Furthermore, the emergency ordinance procedure must be accompanied by a parallel standard ordinance procedure. The standard ordinance must be operative by the time the emergency ordinance expires after one year, since otherwise the temporarily controlled substances will no longer be subject to the Narcotic Drugs Act.